02.09.24 -- Cell & Gene Therapy Regulatory And Compliance Solutions

This multi-capillary electrophoresis system enables scientists to run multiple samples in parallel, accelerating the development and execution of sensitive, high-throughput analytical methods.

Data integrity is a leading issue cited in FDA warning letters, mainly due to incomplete data. Learn how this can be prevented by ensuring compliance with data integrity.

Review the submission process and regulatory expertise which helped a biopharma company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.

Discover a software solution that enables the rapid, pretested, and pre-verified integration of your bioproduction equipment into a central data storage, visualization, and reporting infrastructure.

Learn how CAI helped a client reduce their batch record backlog, minimize their manufacturing error rate, sustain timely productivity and release levels, and meet FDA commitments.

Despite quick growth and logistical challenges, Germfree’s mobile solutions enable distributed manufacturing, ease the collection of patient cells, and help make CGT treatments accessible globally.